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Study temporarily suspended due to company acquisition and ongoing strategic evaluation of the program
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A Phase 3 Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of Delayed Graft Function (DGF) Following Kidney Allograft Transplantation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegceptacoplan | Active Comparator | Administration as a 20mL IV infusion initially, then as a subcutaneous infusion |
|
| Placebo | Placebo Comparator | Administration as a 20mL IV infusion initially, then as a subcutaneous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegcetacoplan | Drug | Complement (C3) Inhibitor |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Time to freedom from dialysis through Day 90 | To assess the efficacy of pegcetacoplan compared with that of placebo in participants at high risk of DGF following donor kidney allograft transplant surgery | Duration of dialysis through day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| eGFR at Week 52 | To evaluate the efficacy of pegcetacoplan in reducing the severity of DGF and consequent improvements in short-, medium- and long-term kidney function and kidney allograph outcomes | 52 weeks following surgery |
| Proportion of participants with DGF (defined as the need for dialysis in the 7 days posttransplant) |
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Inclusion Criteria:
Aged at least 18 years
Have end-stage kidney disease and be on the waiting list for a kidney transplant from a deceased donor.
Be on dialysis at the time of your transplant and produce very little urine (less than 200 mL per day equivalent to ≤1 cup). You must have been on dialysis for at least 3 months.
Be receiving your first or second kidney transplant from a deceased donor. If this is your second transplant:
Be getting a donor kidney that meets the study's specific requirements.
Be at low to medium risk of transplant rejection, and be scheduled to receive:
Have received certain vaccines before starting the study treatment, specifically:
If you haven't had these vaccines, you may still qualify to be part of the study, provided your doctor plans to administer preventive antibiotics until vaccination can be given per protocol, and with notification to the sponsor.
Exclusion Criteria:
Have taken part in another medical research study or used an experimental drug, treatment, or device in the past 30 days (or longer, depending on the drug).
Have recently used certain medications that affect the immune system, such as rituximab, belimumab, or other approved complement-blocking drugs.
Weigh less than 20kg or more than 120kg at screening.
Have or had recently had any of the following infections:
Have had cancer in the past 5 years, unless it was:
Have received any other organ transplant (except for one previous kidney transplant), or are scheduled for a transplant involving more than one organ.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo | São Paulo | 01323-001 | Brazil |
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| Other |
Sterile solution of equal volume to active arm |
|
To evaluate the efficacy of pegcetacoplan in reducing the severity of DGF and consequent improvements in short-, medium- and long-term kidney function and kidney allograph outcomes |
| 7 days following surgery |
| eGFR at Day 90 | To evaluate the efficacy of pegcetacoplan in reducing the severity of DGF and consequent improvements in short-, medium- and long-term kidney function and kidney allograph outcomes | 90 days following surgery |
| Time to achievement of ≥1200 mL of urine output in a 24-hour period through Day 14 | To evaluate the efficacy of pegcetacoplan in reducing the severity of DGF and consequent improvements in short-, medium- and long-term kidney function and kidney allograph outcomes | 14 days following surgery |
| Biopsy-proven rejection-free kidney allograft survival by Week 52 | To evaluate the efficacy of pegcetacoplan in reducing the severity of DGF and consequent improvements in short-, medium- and long-term kidney function and kidney allograph outcomes | 52 weeks following surgery |
| ID | Term |
|---|---|
| D051799 | Delayed Graft Function |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| C000716074 | pegcetacoplan |
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